View Drug - Dextrose
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Dextrose

Generic: DEXTROSE MONOHYDRATE

100%
Basic Information
Manufacturer
REMEDYREPACK INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
e2638b45-1141-4391-971d-c0dea825e41c
Indications & Usage
1 INDICATIONS AND USAGE Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients from birth up to 2 years of age.

Dextrose Injection (25%) is indicated for the treatment of acute symptomatic episodes of hypoglycemia in pediatric patients younger than 2 years old.

( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also described elsewhere in the labeling: Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.1) ] .

Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] .

Phlebitis and Thrombosis [see Warnings and Precautions (5.3) ] Electrolyte Imbalance and Fluid Overload [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash Cardiovascular disorders: cyanosis, volume overload The most common adverse reactions are hyperglycemia, hypersensitivity reactions, hyponatremia, infection (both systemic and at the injection site), vein thrombosis, phlebitis, and electrolyte imbalance.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc.

at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.